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  • 1.  Software as a Medical Device: Clinical Evaluation Guidance

    Posted 08-Dec-2017 10:28
    Yesterday, the FDA released a new guidance document titled "Software as a Medical Device: Clinical Evaluation".  From the very little text that accompanied the announcement, I gathered that the guidance isn't linked to any requirements...YET.  Anyone have any insight?  I just want to ensure I'm not missing anything!
    Thanks!

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    Rene' Hardee
    Sr. Regulatory Affairs Specialist
    Sun Nuclear Corporation
    Melbourne FL
    United States
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  • 2.  RE: Software as a Medical Device: Clinical Evaluation Guidance

    Posted 08-Dec-2017 11:41
    Few guidances for general device types are linked to actual requirements. This guidance helps establish a framework that the FDA would like to see when designing clinical trials for SaMDs. There may be a summary and webinar after the holidays. Other larger private groups will also summarize the guidance. There isn't a whole lot of new information present to me. There has been a division at FDA between separate groups all trying to tackle how to regulate mobile health applications. The latest guidances seem to be merging information as the groups try to harmonize recommendations.

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    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
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    Original Message


  • 3.  RE: Software as a Medical Device: Clinical Evaluation Guidance

    Posted 08-Dec-2017 21:37
    The draft of this guidance was published in Oct 2016. It is different from other <g class="gr_ gr_89 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="89" data-gr-id="89">guidances</g> in that they took a guideline from IMDRF, with some different terminology. It's about validating software using clinical studies. However, I still believe the Pivotal Device Studies explains this much better.

    Yesterday's three <g class="gr_ gr_493 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="493" data-gr-id="493">guidances</g> have to be viewed within the context of the other digital health <g class="gr_ gr_555 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="555" data-gr-id="555">guidances</g>, as well as the other software guidances going back to 2009, and Accessories guidance that came out a year ago.

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    Samir Shah
    Miami FL
    United States
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    Original Message


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